Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

January 30, 2012 updated by: Sanofi

Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine

This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™

Primary Objective - Stage I:

To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).

Primary Objective - Stage II:

To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.

Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.

Study Type

Interventional

Enrollment (Actual)

1167

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
      • Jonesboro, Arkansas, United States, 72401
      • Little Rock, Arkansas, United States, 72205
    • California
      • Fountain Valley, California, United States, 92708
      • Oakland, California, United States, 94612
      • Rolling Hills Estate, California, United States, 90274
    • Connecticut
      • Norwich, Connecticut, United States, 06360
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
      • Louisville, Kentucky, United States, 40202
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Missouri
      • Kansas City, Missouri, United States, 64112
    • New York
      • Brooklyn, New York, United States, 11201
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
      • Pittsburgh, Pennsylvania, United States, 15241
    • Texas
      • Austin, Texas, United States, 78745
      • Fort Worth, Texas, United States, 76107
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78745
    • Utah
      • Layton, Utah, United States, 84041
    • Washington
      • Spokane, Washington, United States, 99220
      • Vancouver, Washington, United States, 98864
    • Wisconsin
      • Lacrosse, Wisconsin, United States, 54601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age.
  • Infants with at least 36 weeks of gestation at delivery.
  • Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines).
  • Able to attend the scheduled visits and to comply with the study procedures.
  • Parent or legal guardian willing to take rectal temperatures during the infant series.
  • Parent or legal guardian has access to a telephone.
  • Signed informed consent from parent or legal guardian obtained before the 1st study intervention.
  • Able to obtain at least 1.5 mL of blood sample prior to Dose 1.

Exclusion Criteria :

  • Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
  • Known or suspected hypersensitivity to any component of the study vaccine to be administered.
  • Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Known Human Immunodeficiency Virus (HIV)-positive mother or child.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay or neurologic disorder.
  • Chronic medical, congenital, or developmental disease.
  • Participation in any other clinical trial.
  • Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
  • Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pentacel™ concurrently with Prevnar®
Participants had Pentacel™ concurrently administered with Prevnar®
Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
Other Names:
  • Prevnar®
  • Pentacel™
Experimental: Pentacel™ staggered schedule with Prevnar®
Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule).
Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
Other Names:
  • Prevnar®
  • Pentacel™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
Time Frame: 28 to 48 days post-3rd vaccination
Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.
28 to 48 days post-3rd vaccination
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
Time Frame: 60 Days Post-dose 3
Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.
60 Days Post-dose 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™
Time Frame: 0-3 days post- vaccination and entire study period
Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.
0-3 days post- vaccination and entire study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M5A07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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